Coronary/Structural Heart

Triple-Gene Announces Completion of Enrollment and Dosing in Phase 1 Trial of INXN‑4001, First Multigenic Investigational Therapeutic Candidate for Treatment of Heart Failure

– Company to Present Preliminary Data at American Heart Association Scientific Sessions – GERMANTOWN, Md., Nov. 7, 2019 /PRNewswire/ — Triple-Gene LLC, a clinical stage cardiovascular gene therapy company and majority owned subsidiary of Intrexon Corporation (NASDAQ: XON), today announced the completion of enrollment and dosing in its Phase 1 trial of INXN-4001, a […]

Saranas Announces First Commercial Case With Early Bird® Bleed Monitoring System in the U.S.

Novel technology offers physicians first and only real-time detection and monitoring of endovascular bleed complications HOUSTON–(BUSINESS WIRE)–Saranas, Inc. today announced completion of the first U.S. commercial case using the Early Bird® Bleed Monitoring System for real-time detection and monitoring of endovascular bleed complications. Dr. Robert Kipperman, co-director of the Structural Heart […]

Edwards SAPIEN 3 TAVI Receives Expanded Approval In Europe

Superior TAVI Valve Indicated for All Patients Diagnosed with Aortic Stenosis IRVINE, Calif., Nov. 6, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark to expand use of the Edwards SAPIEN 3 […]

Neovasc to Submit Full PMA Application for Neovasc Reducer™ in 2019

VANCOUVER, Nov. 01, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that it intends to submit […]

First U.S. Patients Treated with Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump

DANVERS, Mass.–(BUSINESS WIRE)–Three cardiac surgeons at Cleveland Clinic, Hackensack Meridian Health and Cedars-Sinai Medical Center are the first in the United States to implant Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist. Ed Soltesz, MD, Mark Anderson, MD, and Danny Ramzy, MD, have each successfully implanted multiple pumps during cardiac procedures at their hospitals. Mark […]

myTAIHEART Test Provides Evidence for Injury from Biopsy of Heart Transplant Recipients

MILWAUKEE, Wis.–(BUSINESS WIRE)–TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication, “Effect of endomyocardial biopsy on levels of donor-specific cell-free DNA” in the October, 2019 issue of The Journal of Heart and Lung Transplantation. The clinical study presented in the paper was conducted jointly […]

Orsiro Coronary Drug-Eluting Stent Receives Market Approval in China

BIOTRONIK’s Ultrathin-Strut Drug-Eluting Stent Soon Available in China Following Market Approval BEIJING, China and BUELACH, Switzerland, October 30, 2019 – BIOTRONIK announced today that its Orsiro® coronary drug-eluting stent (DES) has been approved for sale in China by the National Medical Products Administration. The company expects to make the device available to Chinese patients […]

New Intermountain Study Aims to Determine the Most Effective Method to Identify People at Risk for Heart Disease Before They Ever Develop Problems

SALT LAKE CITY–(BUSINESS WIRE)–Researchers from the Intermountain Healthcare Heart Institute are launching one of the largest and most ambitious research initiatives ever undertaken in the state of Utah to test a new standard of care to better identify and treat people at risk of having a heart attack – and […]

Toyoda Gosei and EBM Corp. Launch “SupeR BEAT” Medical Simulator Using e-Rubber

KIYOSU, Japan–(BUSINESS WIRE)–Toyoda Gosei Co., Ltd. (TOKYO: 7282) and EBM Corporation1 today launched the “SupeR BEAT” surgical training simulator. This simulator can reproduce the beating of the heart with extreme accuracy using e-Rubber, an innovative material that moves with electricity. The two companies have been collaborating since November 2017 to develop […]

CORRECTING and REPLACING CAPTION FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival

CORRECTION…by Abiomed October 26, 2019 09:15 AM Eastern Daylight Time DETROIT–(BUSINESS WIRE)–Please replace the caption for release dated October 25, 2019 with the accompanying corrected caption. The release reads: FDA POST APPROVAL STUDY DEMONSTRATES TIMELY IDENTIFICATION OF RIGHT HEART FAILURE AND EARLY USE OF IMPELLA RP LEADS TO HIGHER SURVIVAL […]